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The purpose of this study is to determine whether intravenous or oral iron are effective in the treatment of postoperative anemia and iron deficiency in patients submitted in postbariatric abdominoplasty.
Multicenter open randomized clinical trial with allocation ratio 1: 1. 56 adult patients undergoing post- bariatric abdominoplasty will be evaluated. The study group will receive 200 mg of intravenous iron in the immediate postoperative period and a second application on day 1 postoperatively. The control group will receive 100 mg of oral iron twice daily for 8 weeks. Haematological variables , iron 's profile , quality of life ( SF -36 and FACT- An) and adverse events will be assessed preoperatively and on the first , fourth and eighth weeks postoperatively .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Iron | Experimental | Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop. |
|
| Oral Iron | Active Comparator | Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Iron sucrose | Drug | Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin level | Hemoglobin level measured at 8 postoperative weeks | 8 postoperative weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin levels | Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks | |
| FACIT | The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan-Carlos Montano-Pedroso, MD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo | São Paulo | São Paulo | 04024-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29958570 | Derived | Montano-Pedroso JC, Bueno Garcia E, Alcantara Rodrigues de Moraes M, Francescato Veiga D, Masako Ferreira L. Intravenous iron sucrose versus oral iron administration for the postoperative treatment of post-bariatric abdominoplasty anaemia: an open-label, randomised, superiority trial in Brazil. Lancet Haematol. 2018 Jul;5(7):e310-e320. doi: 10.1016/S2352-3026(18)30071-1. | |
| 27068478 |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C013276 | teferrol |
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Oral Iron | Drug | Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks. |
|
|
| Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks |
| SF36 | Quality of Life Questionnaire | Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks |
| Transferrin saturation | Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks |
| Hemoglobin levels | preoperative (one day before surgery) and 1, 4 postoperative weeks |
| Derived |
| Montano-Pedroso JC, Garcia EB, Novo NF, Veiga DF, Ferreira LM. Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial. Trials. 2016 Apr 12;17:196. doi: 10.1186/s13063-016-1300-x. |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |